510(k) K142895

Device: LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
Applicant: FUJIREBIO DIAGNOSTICS, INC
510(k) number: K142895
Product code: LTK
Decision: Substantially Equivalent (SESE)
Decision date: 2015-05-21
Date received: 2014-10-03
Regulation: 866.6010
Classification name: Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
Medical specialty: Immunology
Review panel: Immunology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
04987270234440	Soda Lime for LUMIPULSE System	FUJIREBIO INC.	2020-01-10
04987270234259	LUMIPULSE G1200	FUJIREBIO INC.	2019-12-27
04987270230466	Lumipulse G Dilution Cartridges	FUJIREBIO INC.	2019-12-27
00850212007096	Lumipulse G Wash Solution	FUJIREBIO DIAGNOSTICS, INC.	2017-10-06
04987270234273	Lumipulse G CA125II Immunoreaction Cartridges	FUJIREBIO INC.	2016-09-16
04987270231203	Lumipulse G Specimen Diluent 1	FUJIREBIO INC.	2016-09-16
04987270231197	Lumipulse G Substrate Solution	FUJIREBIO INC.	2016-09-16
04987270231173	Lumipulse G Wash Solution	FUJIREBIO INC.	2016-09-16
04987270230688	Lumipulse G CA125II Calibrators	FUJIREBIO INC.	2016-09-16

summary

Decision Summary